US10575859B2 - Hemostatic device - Google Patents
Hemostatic device Download PDFInfo
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- US10575859B2 US10575859B2 US15/643,096 US201715643096A US10575859B2 US 10575859 B2 US10575859 B2 US 10575859B2 US 201715643096 A US201715643096 A US 201715643096A US 10575859 B2 US10575859 B2 US 10575859B2
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- Prior art keywords
- layer
- inflation portion
- inflation
- hemostatic device
- band
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/132—Tourniquets
- A61B17/135—Tourniquets inflatable
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/132—Tourniquets
- A61B17/1322—Tourniquets comprising a flexible encircling member
- A61B17/1325—Tourniquets comprising a flexible encircling member with means for applying local pressure
Definitions
- the disclosure herein relates to a hemostatic device used for performing hemostasis by compressing a punctured site.
- a known hemostatic device which includes a band for being wrapped around a limb such as the arms and legs, securing means for securing the band in a state where the band is wrapped around the limb, and an inflation portion that interlocks with the band, and that is inflated by injecting a fluid so as to compress the puncture site.
- a physician or a nurse In order to prevent the vascular occlusion, a physician or a nurse generally inflates the inflation portion. Thereafter, he or she periodically connects a dedicated instrument such as a syringe to the hemostatic device, discharges a fluid contained inside the inflation portion, and performs a decompressing operation for reducing internal pressure of the inflation portion, thereby reducing the compressing force acting on the puncture site with the lapse of time.
- a dedicated instrument such as a syringe
- the inflation portion is configured to include a material which stretches with the lapse of time. Therefore, after the inflation portion is inflated by injecting the fluid into the inflation portion, the inflation portion is gradually inflated and deformed by pressure applied from the fluid inside the inflation portion. Whereas the amount of the fluid inside the inflation portion does not substantially decrease, the volume of an internal space of the inflation portion gradually increases. Accordingly, the internal pressure of the inflation portion can be reduced with the lapse of time. In this manner, the compressing force acting on the puncture site can be reduced with the lapse of time.
- the physician or the nurse can save time and effort when performing the decompressing operation.
- the inflation portion is configured to include the material which stretches with the lapse of time, the inflation portion is progressively inflated and deformed with the lapse of time. As a result, a thickness of the inflation portion becomes thinner. From a viewpoint of satisfactorily maintaining strength of the inflation portion, it is conceivable that the thickness of the inflation portion is preferably maintained to some extent.
- the disclosure herein is directed to a hemostatic device which can satisfactorily maintain strength of an inflation portion, which does not need to be operated by a physician or a nurse, and which can reduce a compressing force acting on a hemostasis-requiring site with the lapse of time to such an extent that vascular occlusion can be prevented.
- the disclosure provides a hemostatic device including a band for being wrapped around a hemostasis-requiring site of a limb, securing means for securing the band in a state where the band is wrapped around the limb, and an inflation portion that interlocks with the band, and that is inflated by injecting gas.
- the inflation portion has a first layer formed of a thermosetting elastomer and a second layer which covers an outer surface of the first layer.
- the first layer is formed of a material which has a larger gas permeation amount per unit area than a material for forming the second layer.
- the second layer has a gap portion which can expose the outer surface of the first layer outward from the second layer in a state where the inflation portion is inflated.
- the outer surface of the first layer can be exposed outward from the second layer via the gap portion of the second layer.
- the first layer is formed of the material which has the larger gas permeation amount per unit area than the material for forming the second layer. Therefore, in the inflation portion, while the compressing force acting on the hemostasis-requiring site is maintained via the first layer, the gas contained inside the inflation portion is discharged outward from the inflation portion with the lapse of time.
- the inflation portion has a double layer structure including the first layer and the second layer. Accordingly, it is possible to improve the strength of the inflation portion.
- the hemostatic device can satisfactorily maintain the strength of the inflation portion, does not need to be operated by a physician or a nurse, and can reduce the compressing force acting on the hemostasis-requiring site with the lapse of time to such an extent that the vascular occlusion can be prevented.
- FIG. 1 is a plan view when a hemostatic device according to an exemplary embodiment of the disclosure is viewed from an inner surface side.
- FIG. 2 is a sectional view taken along line 2 - 2 in FIG. 1 .
- FIG. 3 is a plan view illustrating an inflation portion of the hemostatic device according to the exemplary embodiment of the disclosure.
- FIG. 4 is a perspective view illustrating a state where the hemostatic device according to the exemplary embodiment is worn on a wrist.
- FIG. 5(A) is a sectional view taken along line 5 - 5 in FIG. 4
- FIG. 5(B) is a partial enlarged view in the reference numeral 5 B in FIG. 5(A) .
- FIG. 6 is a view illustrating a state where an outer surface of a first layer is exposed outward from a second layer.
- FIG. 7 is a sectional view taken along line 7 - 7 in FIG. 4 .
- FIG. 8 is a sectional view of a hemostatic device according to a first modified exemplary embodiment.
- FIG. 9 is a sectional view of a hemostatic device according to a second modified exemplary embodiment.
- a hemostatic device 10 As illustrated in FIGS. 4 and 6 , a hemostatic device 10 according to the exemplary embodiment of the disclosure herein is used for performing hemostasis on a puncture site P (corresponding to a “hemostasis-requiring site”) formed in a radial artery R of a wrist W (corresponding to a “limb”) in order to insert a catheter for performing treatment and examination into a blood vessel, after an introducer sheath indwelling the puncture site P is removed.
- a puncture site P corresponding to a “hemostasis-requiring site”
- a radial artery R of a wrist W corresponding to a “limb”
- the hemostatic device 10 has a band 20 for being wrapped around the wrist W, a surface fastener 30 (corresponding to “securing means”) for securing the band 20 in a state where the band 20 is wrapped around the wrist W, an inflation portion 40 that is inflated by injecting gas so as to compress the puncture site P, a marker 40 c for aligning the inflation portion 40 with the puncture site P, and an injection portion 60 that can inject gas into the inflation portion 40 .
- the band 20 includes a belt 21 configured to include a flexible belt-like member, and a support plate 22 which is more rigid than the belt 21 .
- the belt 21 is wrapped substantially one time around an outer periphery of the wrist W.
- a support plate holder 21 a for holding the support plate 22 is formed in a central portion of the belt 21 .
- the support plate holder 21 a is adapted to have a double layer construction in such a way that a separate belt-like member is joined to the outer surface side (or the inner surface side) by means of fusion bonding (heat-welding, high frequency fusion, or ultrasound fusion) or adhesion (adhesion using an adhesive or a solvent), thereby holding the support plate 22 inserted into a gap or pocket formed between the double layer structure.
- a male side (or a female side) 31 of the surface fastener 30 such as a hook and loop fastener (e.g., a product commonly known as VELCRO® or Magic Tape in Japan, is disposed on the outer surface side of a portion in the vicinity of the left end in FIG. 1 of the belt 21 , and a female side (or a male side) 32 of the surface fastener 30 is disposed on the inner surface side of a portion in the vicinity of the right end in FIG. 1 of the belt 21 .
- the belt 21 is wrapped around the wrist W, and the male side 31 and the female side 32 are joined to each other. In this manner, the band 20 is worn on the wrist W.
- means for securing the band 20 in a state where the band 20 is wrapped around the wrist W may be a snap, a button, a clip, or a frame member passing through the end portion of the belt 21 , for example.
- a configuration material of the belt 21 is not particularly limited as long as the material is flexible.
- these materials include polyolefin such as polyvinyl chloride, polyethylene, polypropylene, polybutadiene, and ethylene-vinyl acetate copolymer (EVA), polyester such as polyethylene terephthalate (PET) and polybutylene terephthalate (PBT), various thermoplastic elastomers such as polyvinylidene chloride, silicone, polyurethane, polyamide elastomer, polyurethane elastomer, and polyester elastomer, or any optional combination thereof (blend resin, polymer alloy, and laminate).
- polyolefin such as polyvinyl chloride, polyethylene, polypropylene, polybutadiene, and ethylene-vinyl acetate copolymer (EVA)
- PET polyethylene terephthalate
- PBT polybutylene terephthalate
- various thermoplastic elastomers such as polyvinylid
- the belt 21 can interlock with the inflation portion 40 by means of fusion bonding. Accordingly, it is preferable that the belt 21 is configured to include the thermoplastic material.
- an interlock region 21 b in the exemplary embodiment, as illustrated in FIG. 2 , a region between a region having a first curved portion 22 b of the support plate 22 (to be described later) and a region to which the male side 31 of the surface fastener 30 is attached
- a portion other than the interlock region 21 b may be formed of a material other than the thermoplastic material.
- the belt 21 is configured to include a material having higher elastic modulus than a material configuring a first layer 41 of the inflation portion 40 (to be described later).
- a thermoplastic material can be used as the configuration material of the belt 21 .
- the thermoplastic material it is possible to use a thermoplastic resin such as polyvinyl chloride, polyethylene, polypropylene, and polyvinylidene chloride, or various thermoplastic elastomers such as olefinic thermoplastic elastomer and styrene thermoplastic elastomer. Since the belt 21 is formed of this material, the belt 21 is relatively less likely to stretch. Without being affected by a wearer's size of the wrist W, it is possible to suitably maintain a state where the inflation portion 40 is wrapped around the wrist W.
- a portion overlapping at least the inflation portion 40 in the belt 21 is substantially transparent.
- the portion may be translucent or colored transparent. In this manner, the puncture site P is visible from the outer surface side, thereby enabling the marker 40 c (to be described later) to easily align with the puncture site P.
- the support plate 22 is inserted between the support plate holder 21 a formed to have the double structures of the belt 21 . In this manner, the support plate 22 is held by the belt 21 .
- the support plate 22 has a plate shape in which at least a portion thereof is curved toward the inner surface side (wearing surface side).
- the support plate 22 is configured to include a material which is more rigid than that of the belt 21 , and is adapted to maintain a substantially constant shape.
- the method of providing the support plate 22 in or on the belt 21 is not limited to the illustrated arrangement, and may involve joining the support plate 22 to the inner surface side or the outer surface side of the band 20 by a suitable method such as welding or adhesion. Also, another acceptable arrangement is one in which the belt 21 is connected to both ends of the support plate 22 . It is thus not necessary for a portion of the belt 21 to overlap with the support plate 22 .
- the support plate 22 has a long shape in the longitudinal direction of the belt 21 .
- a central portion 22 a in the longitudinal direction of the support plate 22 is hardly curved, and has a flat plate or generally planar shape. Both sides of the central portion 22 a respectively have a first curved portion 22 b (left side in FIG. 2 ) and a second curved portion 22 c (right side in FIG. 2 ) which are curved toward the inner surface side and along the longitudinal direction (circumferential direction of the wrist W) of the belt 21 .
- configuration materials of the support plate 22 include acrylic resin, polyvinyl chloride (particularly, rigid polyvinyl chloride), polyethylene, polypropylene, polyolefin such as polybutadiene, polystyrene, poly-(4-methylpentene-1), polycarbonate, ABS resin, polymethyl methacrylate (PMMA), polyacetal, polyacrylate, polyacrylonitrile, polyvinylidene fluoride, ionomer, acrylonitrile-butadiene-styrene copolymer, polyethylene terephthalate (PET), polyester such as polybutylene terephthalate (PBT), butadiene-styrene copolymer, aromatic or aliphatic polyamide, and fluorine-based resin such as polytetrafluoroethylene.
- polyvinyl chloride particularly, rigid polyvinyl chloride
- polyethylene polypropylene
- polyolefin such as polybutadiene, polystyrene, poly-(
- a portion overlapping the inflation portion 40 is substantially transparent.
- the portion may be translucent or colored transparent.
- the puncture site P is reliably visible from the outer surface side, thereby enabling the marker 40 c (to be described later) to easily align with the puncture site P.
- the support plate 22 may not have a portion which has a flat plate shape like the central portion 22 a , that is, the support plate 22 may be curved over the entire length.
- the inflation portion 40 is provided with a function to apply a compressing force to the puncture site P after being inflated by injecting gas, and a function to reduce the compressing force acting on the puncture site P with the lapse of time by discharging the injected gas outward with the lapse of time.
- the gas injected into the inflation portion 40 is not particularly limited. For example, air can be used.
- the inflation portion 40 has the first layer 41 and a second layer 42 which covers an outer surface of the first layer 41 .
- the first layer 41 is formed of a material which has a larger gas permeation amount per unit area than a material for forming the second layer 42 . Specifically, it is preferable that the first layer 41 is formed of a thermosetting elastomer. As illustrated in FIGS. 1 and 3 , the first layer 41 is provided with a substantially rectangular outer shape in a plan view. As illustrated in FIG. 6 , the first layer 41 is configured so that the first layer 41 can be exposed outward from the second layer 42 via gap portions 43 a and 44 a of the second layer 42 (to be described later), when the inflation portion 40 is inflated. More specifically, the first layer 41 is configured to protrude from the gap portions 43 a and 44 a , when the inflation portion 40 is inflated.
- the outer surface of the first layer 41 is secured to an inner surface of the second layer 42 at a location within the second layer 42 , except for the gap portion 44 a included in a second sheet 44 of the second layer 42 (to be described later). Therefore, when the first layer 41 protrudes from the gap portions 43 a and 44 a , it is possible to prevent the whole first layer 41 from being exposed from the inside of the second layer 42 .
- the first layer 41 and the second layer 42 are secured to each other at one or more locations in order to prevent the whole first layer 41 from being exposed from the inside of the second layer 42 , when the inflation portion 40 is inflated.
- the outer surface of the first layer 41 is secured to the inner surface of the second layer 42 at a location other than the gap portions 43 a and 44 a in the second layer 42 .
- securing portions 49 are respectively disposed at four locations of an end portion (end portion of the inflation portion 40 along a width direction of the band 20 ) of the inflation portion 40 located in a lateral direction in the drawing so as to form a predetermined gap g between the first layer 41 and the second layer 42 , in a state where the inflation portion 40 is inflated. That is, the first layer 41 and the second layer 42 are not secured to one another except at the securing portions 49 . Thus, in a state where the inflation portion 40 is not inflated, the inflation portion 40 has a gap between the first layer 41 and the second layer 42 .
- the inflation portion 40 when the inflation portion 40 is inflated and then the gap portions 43 a , 44 a are opened, the second layer 42 , having been enlarged by the first layer 41 , then returns to its original shape due to contraction of the second layer 41 . Thus, the inflation portion 40 forms a gap g between the first layer 41 and the second layer 42 .
- the gap g formed between the first layer 41 and the second layer 42 causes the gas contained inside the first layer 41 to be discharged (permeated) outward via the gap g. Therefore, a discharge rate of the gas discharged from the first layer 41 can be properly adjusted by properly adjusting a surface area exposed from the second layer 42 by the first layer 41 , thickness of the first layer 41 , or a size of the gap g.
- the second layer 42 may include at least one or more gap portions. In this case, for the following reason, it is preferable to dispose the gap portion on the first sheet 43 side of the second layer 42 . If the gap portion 43 a is formed on a surface (surface on a side facing the band 20 ) on the first sheet 43 side of the second layer 42 , when the first layer 41 protrudes from the gap portion 43 a , a space can be formed between the inflation portion 40 and the band 20 . In this manner, the gas can be efficiently discharged from the first layer 41 .
- the second layer 42 is configured to cover the first layer 41 , in a state before the inflation portion 40 is inflated.
- the second layer 42 is configured so that a portion of the first layer 41 protrudes from the second layer 42 , in a state where the inflation portion 40 is inflated.
- the second layer 42 is configured to include a material having a smaller gas permeation amount per unit area than a material configuring the first layer 41 .
- the material configuring the first layer 41 is a thermosetting elastomer
- the second layer 42 is formed of a thermoplastic resin which has lower gas permeability than the thermosetting elastomer configuring the first layer 41 .
- the thermoplastic resin it is possible to use polyvinyl chloride, polyethylene, polypropylene, and polyvinylidene chloride.
- the second layer 42 is configured in a bag-like shape in which the first sheet 43 and the second sheet 44 overlap each other.
- the first sheet 43 and the second sheet 44 are provided with a substantially rectangular outer shape which is slightly larger than the first layer 41 in a plan view.
- the first sheet 43 has the gap portion 43 a which can expose the outer surface of the first layer 41 outward from the first sheet 43 , in a state where the inflation portion 40 is inflated.
- the size of the gap portion 43 a is appropriately adjusted. In this manner, it is possible to adjust the amount of the first layer 41 protruding from the gap portion 43 a . Note that, the outer surface of the first layer 41 protruding from the gap portion 43 a may come into contact with the belt 21 .
- the gap portion 43 a is configured to be closed by being temporarily secured in a state before the inflation portion 40 is inflated.
- the securing method is not particularly limited, an adhering method using an adhesive may be used, for example.
- the gap portion 43 a is switched from a closed state to an open state when the inflation space 40 a inside the inflation portion 40 reaches a predetermined pressure. That is, the gap portion 43 a in the closed state is opened when the inflation space 40 a inside the inflation portion 40 reaches the predetermined pressure. Therefore, the inflation portion 40 can prevent initial decompression, and can appropriately adjust a starting time of automatic decompression.
- the second sheet 44 has the gap portion 44 a which can expose the outer surface of the first layer 41 outward from the second sheet 44 , in a state where the inflation portion 40 is inflated.
- the outer surface of the first layer 41 protruding from the gap portion 44 a comes into contact with the puncture site P.
- the size of the gap portion 44 a is appropriately adjusted. In this manner, it is possible to adjust the amount of the first layer 41 protruding from the gap portion 44 a.
- the gap portion 44 a is configured to be closed by being temporarily secured in a state before the inflation portion 40 is inflated.
- the securing method is not particularly limited, an adhering method using an adhesive may be used, for example.
- the gap portion 44 a is switched from a closed state to an open state when the inflation space 40 a inside the inflation portion 40 reaches a predetermined pressure. That is, the gap portion 44 a in the closed state is opened when the inflation space 40 a inside the inflation portion 40 reaches the predetermined pressure. Therefore, the inflation portion 40 can prevent initial decompression, and can appropriately adjust a starting time of automatic decompression.
- the first sheet 43 has a protruding portion 43 c protruding outward from a rectangular portion in a plan view.
- the second sheet 44 has a protruding portion 44 c protruding outward from a rectangular portion in a plan view.
- the tube 61 of the injection portion 60 (to be described later) is disposed between the protruding portion 43 c of the first sheet 43 and the protruding portion 44 c of the second sheet 44 .
- the protruding portions 43 c and 44 c adhere to the tube 61 by using an adhesive. In this manner, the tube 61 is held by the inflation portion 40 .
- an outer shape of the first sheet 43 and the second sheet 44 is not particularly limited to the above-described shape.
- circular, elliptical, and polygonal shapes may be employed.
- the protruding portions 43 c and 44 c may not be provided.
- the inflation portion 40 is disposed in a state where the first sheet 43 faces the inner surface side of the band 20 . Accordingly, one side of the first sheet 43 is fused to the inner surface side of the interlock region 21 b of the band 20 .
- a fusion portion between the inflation portion 40 and the band 20 is referred to as a “first fusion portion F 1 ” (refer to FIG. 3 ).
- the first sheet 43 formed of the thermoplastic resin is fused to the interlock region 21 b of the band 20 formed of the thermoplastic resin. In this manner, the inflation portion 40 and the band 20 can interlock with each other by means of fusion bonding.
- the peripheral edge portion of the first sheet 43 and the peripheral edge portion of the second sheet 44 can be fused to each other except for a portion into which the tube 61 of the injection portion 60 (to be described later) is inserted.
- a fusion portion between the peripheral edge portion of the first sheet 43 and the peripheral edge portion of the second sheet 44 is referred to as a “second fusion portion F 2 ”.
- the peripheral edge portion of the first sheet 43 and the peripheral edge portion of the second sheet 44 may adhere to each other by using an adhesive.
- thermoplastic material used for the first sheet 43 is the same material as the thermoplastic material used for the interlock region 21 b of the band 20 , a binding force between the first sheet 43 and the band 20 in the first fusion portion F 1 can be strengthened.
- thermoplastic material used for the first sheet 43 and the thermoplastic material used for the interlock region 21 b of the band 20 may be different from each other.
- thermoplastic material used for the first sheet 43 is the same material as the thermoplastic material used for the second sheet 44
- a binding force between the first sheet 43 and the second sheet 44 in the second fusion portion F 2 can be strengthened.
- the thermoplastic material used for the first sheet 43 and the thermoplastic material used for the second sheet 44 may be different from each other.
- thermosetting elastomer used for the first layer 41 is provided with higher gas permeability than the thermoplastic resin used for the second layer 42 . Therefore, as illustrated in FIG. 6 , in a state where the first layer 41 protrudes via the gap portions 43 a and 44 a after the inflation portion 40 is inflated, the gas contained inside the inflation portion 40 is discharged outward from the inflation portion 40 with the lapse of time via the first layer 41 to such an extent that the vascular occlusion can be prevented. Therefore, even if a physician or a nurse does not perform the decompressing operation, the compressing force applied to the puncture site P by the inflation portion 40 can be decreased with the lapse of time.
- the first layer 41 formed of the thermosetting elastomer has the relatively high gas permeability. Accordingly, it is not necessary to excessively reduce the thickness of the inflation portion 40 in order to increase the gas permeation amount, and it is possible to satisfactorily maintain the strength of the inflation portion 40 .
- a gas permeability coefficient of the thermosetting elastomer used for the first layer 41 is ten times or more greater than a gas permeability coefficient of the thermoplastic material used for the second layer 42 , more preferably 100 times or more, and most preferably 1,000 times or more.
- the hemostatic device 10 can suitably adjust the compressing force which is applied to the puncture site P by the inflation portion 40 and which is reduced with the lapse of time.
- the thermoplastic material used for the second layer 42 is the thermoplastic resin.
- thermoplastic resin used for the second layer 42 has a higher elastic modulus than the thermosetting elastomer used for the first layer 41 . Therefore, the first layer 41 can be stretched and easily protruded from the gap portion 44 a , thereby enabling the first layer 41 to locally apply the compressing force to the wrist W.
- the puncture site P is compressed by the inflation portion 40 for four hours after the inflation portion 40 is inflated.
- the internal pressure of the inflation portion 40 is decompressed with the lapse of time. In this manner, it is preferable to reduce the compressing force applied to the puncture site P by the inflation portion 40 with the lapse of time.
- thermosetting elastomer of the first layer 41 protruding from the gap portions 43 a and 44 a so as to satisfy the following two conditions:
- Condition 1 and Condition 2 may be substituted with Condition 3 and Condition 4 below:
- the thickness and the surface area of the first layer 41 it is necessary to appropriately set the thickness and the surface area of the first layer 41 .
- the first layer 41 by using a thermosetting elastomer whose gas permeability coefficient is 75 to 550 ⁇ 10 ⁇ 8 cc ⁇ cm/cm 2 ⁇ sec ⁇ atm (preferably, 200 to 400 ⁇ 10 ⁇ 8 cc ⁇ cm/cm 2 ⁇ sec ⁇ atm).
- this material includes silicone rubber.
- the inflation portion 40 has the first layer 41 formed of the thermosetting elastomer, and the second layer 42 which covers the outer surface of the first layer 41 and which is formed of the thermoplastic resin having the lower gas permeability than the thermosetting elastomer.
- the second layer 42 has the gap portions 43 a and 44 a which can expose the outer surface of the first layer 41 outward from the second layer 42 in a state where the inflation portion 40 is inflated. Therefore, after the inflation portion 40 is inflated, the gas contained inside the inflation portion 40 is discharged outward from the inflation portion 40 with the lapse of time via the first layer 41 formed of the thermosetting elastomer to such an extent that the vascular occlusion can be prevented.
- the inflation portion 40 is disposed on the inner surface side of the band 20 . Therefore, if the inflation portion 40 is inflated, the band 20 restrains the inflation portion 40 from being inflated in a direction separated from the body surface of the wrist W. In this manner, the compressing force of the inflation portion 40 is concentrated on the wrist W side. Accordingly, it is possible to suitably apply the compressing force to the puncture site P.
- the inflation portion 40 is wrapped around the wrist W by the band 20 , and the internal pressure increases. Accordingly, the gas contained inside the inflation portion 40 can be suitably discharged outward. Furthermore, it is possible to suitably prevent the discharge of the gas contained inside the inflation portion 40 from being hindered in such a way that a patient wearing the hemostatic device 10 inadvertently touches the first layer 41 .
- the inflation portion 40 is substantially transparent.
- the portion may be translucent or colored transparent. In this manner, the puncture site P is visible from the outer surface side, thereby enabling the marker 40 c (to be described later) to easily align with the puncture site P.
- the marker 40 c is disposed on the inner surface of the first layer 41 . Since this marker 40 c is disposed in the inflation portion 40 , the inflation portion 40 can easily align with the puncture site P. Accordingly, misalignment of the inflation portion 40 is restrained. In addition, since the marker 40 c is disposed on the inner surface side of the first layer 41 , the marker 40 c does not directly come into contact with the puncture site P. Note that, a position for disposing the marker 40 c is not particularly limited as long as the inflation portion 40 can align with the puncture site P.
- a shape of the marker 40 c includes circular, triangular, and square shapes, for example.
- the marker 40 c has the square shape.
- a size of the marker 40 c is not particularly limited. However, for example, in a case where the shape of the marker 40 c is the square shape, it is preferable that one side length thereof is in a range of 1 to 4 mm. If one side length is 5 mm or longer, the size of the marker 40 c is larger than the size of the puncture site P. Consequently, the central portion of the inflation portion 40 is less likely to align with the puncture site P.
- a material of the marker 40 c includes oily colorants such as ink, and resins kneaded with pigments.
- a color of the marker 40 c is not particularly limited as long as the color enables the inflation portion 40 to align with the puncture site P. However, it is preferable that the color is a green color system. If the green color system is used, the marker 40 c is easily visible on the blood or the skin. Accordingly, the inflation portion 40 is much likely to align with the puncture site P.
- the marker 40 c is translucent or colored transparent. In this manner, the puncture site P is visible from the outer surface side of the marker 40 c.
- a method of disposing the marker 40 c in the inflation portion 40 is not particularly limited. However, for example, the method includes a method of printing the marker 40 c on the inflation portion 40 , and a method of attaching the marker 40 c to the inflation portion 40 by applying an adhesive to one side surface of the marker 40 c.
- the injection portion 60 is used for injecting the gas into the inflation portion 40 . As illustrated in FIG. 1 , the injection portion 60 is connected to the inflation portion 40 .
- the proximal portion of the injection portion 60 is connected to the inflation portion 40 .
- the injection portion 60 includes a flexible tube 61 whose lumen communicates with the inside of the inflation portion 40 , a bag 62 which is disposed in the distal portion of the tube 61 so as to communicate with the lumen of the tube 61 , and a tubular connector 63 connected to the bag 62 and which has a check valve (not illustrated) incorporated therein.
- the tube 61 is connected to the inflation portion 40 so as to be interposed between the protruding portion 43 c of the first sheet 43 and the protruding portion 44 c of the second sheet 44 .
- a connecting position of the tube 61 to the inflation portion 40 is not particularly limited as long as the lumen of the tube 61 communicates with the internal space of the inflation portion 40 .
- a distal tubular portion of a syringe (not illustrated) is inserted into the connector 63 so as to open the check valve.
- a plunger of the syringe is pressed, and the gas contained in the syringe is injected into the inflation portion 40 via the injection portion 60 .
- the bag 62 communicating with the inflation portion 40 via the tube 61 is inflated. It is possible to visually confirm that the inflation portion 40 can be pressurized without leakage of the gas. If the distal tubular portion of the syringe is removed from the connector 63 after the gas is injected into the inflation portion 40 , the check valve incorporated in the connector 63 is closed, thereby preventing the leakage of the gas.
- the inflation portion 40 is in a non-inflated state as illustrated in FIG. 2 .
- the puncture site P is located at a position close to the thumb side.
- the introducer sheath indwells the puncture site P.
- the band 20 is wrapped around the wrist W left in a state where the introducer sheath indwells the puncture site P.
- the marker 40 c disposed in the inflation portion 40 aligns with the inflation portion 40 and the band 20 so as to overlap the puncture site P from above.
- the male side 31 and the female side 32 of the surface fastener 30 are brought into contact with and joined to each other. In this manner, the band 20 is worn on the wrist W.
- the hemostatic device 10 is worn on the wrist W so that the injection portion 60 faces the downstream side (palm side) of the blood flow in the radial artery R.
- the injection portion 60 can be operated without interfering with a manual skill on the upstream side from the wrist or an instrument (for example, a blood pressure monitor) located on the upstream side.
- the hemostatic device 10 is worn on the wrist W of the right hand so that the injection portion 60 faces downstream side.
- the inflation portion 40 is located in the radial artery R located close to the thumb side of the wrist W.
- the upstream side of the blood vessel indicates a direction closer to the heart of the blood vessel.
- the downstream side of the blood vessel indicates a direction farther away from the heart of the blood vessel.
- the hemostatic device 10 may be used in a case where the radial artery of the wrist of the left hand is punctured.
- the injection portion 60 is worn on the wrist W of the left hand so as to face the upstream side of the blood flow in the radial artery.
- the syringe (not illustrated) is connected to the connector 63 of the injection portion 60 . As described above, the gas is injected into the inflation portion 40 , and the inflation portion 40 is inflated.
- the inflation portion 40 opens the gap portions 43 a and 44 a . Then, the outer surface of the first layer 41 protrudes from the gap portion 43 a and comes into contact with the belt 21 . In addition, the outer surface of the first layer 41 protrudes from the gap portion 44 a and comes into contact with and presses the puncture site P, thereby performing the hemostasis on the puncture site P.
- an amount of the gas injected is adjusted in accordance with a clinical case.
- an inflated degree of the inflation portion 40 that is, the compressing force acting on the puncture site P can be easily adjusted.
- the inflation portion 40 is excessively inflated since too much gas is injected into the inflation portion 40 , the excessively injected gas may be discharged from the inside of the inflation portion 40 by using the syringe.
- the first layer 41 of the inflation portion 40 is formed of the thermosetting elastomer, the first layer 41 is elastic. Therefore, if the gas excessively injected into the inflation portion 40 is discharged outward, the inflation portion 40 is contracted and deformed in response to the discharge.
- the inflation portion 40 has a desired inflation degree, and can apply the suitable compressing force to the puncture site P.
- the syringe is detached from the connector 63 . Then, the introducer sheath is removed from the puncture site P.
- the gas contained inside the inflation portion 40 is discharged outward from the inflation portion 40 with the lapse of time.
- the size of the gap portions 43 a and 44 a is appropriately adjusted. In this manner, it is possible to adjust the amount of the first layer 41 protruding from the gap portions 43 a and 44 a . Therefore, when the gas contained inside the inflation portion 40 is discharged outward from the inflation portion 40 via the first layer 41 , the gas permeation amount can be appropriately adjusted.
- the internal pressure of the inflation portion 40 may be increased by injecting additional gas into the inflation portion 40 .
- additional gas may be injected to correspond to the amount of gas discharged from the inflation portion 40 .
- the hemostatic device 10 is detached from the wrist W.
- the hemostatic device 10 is detached from the wrist W by separating the male side 31 and the female side 32 of the surface fastener 30 from each other.
- the hemostatic device 10 has the band 20 for being wrapped around the puncture site P of the wrist W, the securing means 30 for securing the band 20 in a state where the band 20 is wrapped around the wrist W, and the inflation portion 40 that interlocks with the band 20 , and that is inflated by injecting the gas.
- the inflation portion 40 has the first layer 41 and the second layer 42 which covers the outer surface of the first layer 41 .
- the first layer 41 is formed of the material which has a larger gas permeation amount per unit area than the material for forming the second layer 42 .
- the second layer 42 has the gap portions 43 a and 44 a which can expose the outer surface of the first layer 41 outward from the second layer 42 in a state where the inflation portion 40 is inflated.
- the outer surface of the first layer 41 can be exposed outward from the second layer 42 via the gap portions 43 a and 44 a of the second layer 42 .
- the first layer 41 is formed of the material which has the larger gas permeation amount per unit area than the material for forming the second layer 42 . Therefore, in the inflation portion 40 , while the compressing force applied to the puncture site P is maintained via the first layer 41 , the gas contained inside the inflation portion 40 is discharged outward from the inflation portion 40 with the lapse of time.
- the inflation portion 40 has the double layer structure including the first layer 41 and the second layer 42 . Accordingly, it is possible to improve the strength of the inflation portion 40 .
- the hemostatic device 10 can satisfactorily maintain the strength of the inflation portion 40 , does not need to be operated by a physician or a nurse, and can reduce the compressing force acting on the hemostasis-requiring site with the lapse of time to such an extent that the vascular occlusion can be prevented.
- the hemostatic device 10 configured as described above, when the hemostatic device 10 is not used, the outer surface of the first layer 41 is not exposed outward from the first layer 41 . Therefore, it is possible to prevent the gas permeability of the first layer 41 from becoming poor due to dust adhering to the first layer 41 .
- the first layer 41 is formed of the thermosetting elastomer
- the second layer 42 is formed of the thermoplastic resin having the lower gas permeability than the thermosetting elastomer. Therefore, since the first layer 41 formed of the thermosetting elastomer has the relatively high gas permeability, it is not necessary to excessively reduce the thickness of the first layer 41 in order to improve the gas permeability. Therefore, it is possible to more satisfactorily maintain the strength of the inflation portion.
- the band 20 is formed of the thermoplastic resin, and has the interlock region 21 b with which the inflation portion 40 interlocks.
- the second layer 42 of the inflation portion 40 is fused to the interlock region 21 b of the band 20 . Therefore, since the second layer 42 and the interlock region 21 b are fused to each other, it is possible to provide the hemostatic device 10 in which the inflation portion 40 and the band 20 interlock with each other by means of fusion bonding.
- the first layer 41 is secured to the inner surface of the second layer 42 . Therefore, when the first layer 41 protrudes from the gap portions 43 a and 44 a , the inflation portion 40 can prevent the whole first layer 41 from being exposed from the inside of the second layer 42 . In addition, since the exposure amount of the first layer 41 is adjusted, the gas discharge amount discharged from the inflation portion 40 can be more accurately controlled. Furthermore, the first layer 41 protruding from the gap portion 44 a can locally compress the wrist W. Accordingly, it is possible to improve the hemostasis effect.
- the first layer 41 protrudes from the gap portions 43 a and 44 a in a state where the inflation portion 40 is inflated. Therefore, after the inflation portion 40 is inflated, through the first layer 41 protruding from the gap portions 43 a and 44 a , the gas contained inside the inflation portion 40 can be more efficiently discharged outward from the inflation portion 40 with the lapse of time.
- the gap portions 43 a and 44 a of the second layer 42 are temporarily secured so as to be openable when the inflation space 40 a inside the inflation portion 40 reaches a predetermined pressure. Therefore, it is possible to prevent initial decompression, and it is possible to appropriately adjust a starting time of automatic decompression.
- the gap portion 43 a is formed on a surface on a side facing the band 20 in the second layer 42 . Therefore, if the inflation portion 40 is inflated, the band 20 restrains the inflation portion 40 from being inflated in a direction separated from the body surface of the wrist W. In this manner, the compressing force of the inflation portion 40 is concentrated on the wrist W side. Accordingly, it is possible to suitably apply the compressing force to the puncture site P.
- the gap portion 43 a is formed on a surface (surface on the first sheet 43 side) on the side facing the band 20 in the second layer 42 . Accordingly, when the first layer 41 protrudes from the gap portion 43 a , it is possible to form a space between the inflation portion 40 and the band 20 . In this manner, the gas can be efficiently discharged from the first layer 41 .
- FIG. 8 is a view corresponding to FIG. 7 of a hemostatic device 100 according to a first modified exemplary embodiment.
- the same reference numerals will be given to configurations the same as those according to the above-described exemplary embodiment, and description thereof will be omitted.
- an inflation portion 140 included in the hemostatic device 100 according to the first modified exemplary embodiment has the first layer 41 and a second layer 142 which covers the outer surface of the first layer 41 .
- the first layer 41 is configured to be exposable outward from the second layer 142 via gap portions 143 a , 143 b , 143 c , 143 d , 143 e , and 143 f of the second layer 142 (to be described later), when the inflation portion 140 is inflated.
- the second layer 142 is configured in a bag-like shape in which a first sheet 143 and the second sheet 44 overlap each other.
- a configuration of the second sheet 44 is provided with the same configuration as the second sheet 44 according to the above-described exemplary embodiment, and thus, description thereof will be omitted.
- the first sheet 143 has six gap portions 143 a , 143 b , 143 c , 143 d , 143 e , and 143 f which can expose the outer surface of the first layer 41 outward from the first sheet 143 , in a state where the inflation portion 140 is inflated.
- the gap portions 143 a , 143 b , 143 c , 143 d , and 143 e are formed on a surface on the side facing the band 20
- the gap portion 143 f is formed on a surface on the side facing the body surface of the wrist W.
- Each of the gap portions 143 a , 143 b , 143 c , 143 d , and 143 e is configured to cause the first layer 41 to protrude with a relatively short distance (area) along the traveling direction of the radial artery R.
- the gap portion 143 f is configured to cause the first layer 41 to protrude with a relatively long distance (area) along the traveling direction of the radial artery R.
- the hemostatic device 100 of first modified exemplary embodiment described above after the inflation portion 140 is inflated, through the first layer 41 protruding from the gap portions 143 a , 143 b , 143 c , 143 d , 143 e , and 144 f , the gas contained inside the inflation portion 140 can be more efficiently discharged outward from the inflation portion 140 with the lapse of time.
- the first layer 41 is configured to protrude from the gap portion 143 f on the surface on the side facing the body surface of the wrist W in the inflation portion 40 with the relatively long area along the radial artery R. Accordingly, it is possible to improve the hemostasis effect.
- the number of gap portions disposed in the single inflation portion 40 can be appropriately changed.
- FIG. 9 is a view corresponding to FIG. 6 of a hemostatic device 200 according to a second modified exemplary embodiment.
- the same reference numerals will be given to configurations the same as those according to the above-described embodiment, and description thereof will be omitted.
- the hemostatic device 200 according to the second modified exemplary embodiment is different from that according to the above-described exemplary embodiment in that an auxiliary compression portion 270 is provided between the inflation portion 40 and the band 20 .
- the auxiliary compression portion 270 is formed in a bag-like shape.
- the auxiliary compression portion 270 is attached to the first sheet 43 of the inflation portion 40 so that an internal space thereof communicates with the internal space of the inflation portion 40 . Therefore, if the gas is injected into the inflation portion 40 , the auxiliary compression portion 270 is also inflated.
- the auxiliary compression portion 270 may be configured to include a sponge-like substance, an elastic material, an aggregate of fibers such as cotton, or a combination thereof.
- the auxiliary compression portion 270 can adjust the direction of the compressing force applied by the inflation portion 40 so as to be the direction oriented to the puncture site P.
- the auxiliary compression portion 270 is disposed in the first sheet 43 . Accordingly, the first layer 41 protruding from the gap portion 43 a can increase an area of the exposed portion without coming into contact with the band 20 . Therefore, the gas can be more satisfactorily discharged from the exposed portion.
- the hemostatic device according to the disclosure herein has been described with reference to the exemplary embodiment and the modified examples. However, without being limited to only the respectively described configurations, the disclosure can be appropriately modified based on the description in the appended claims.
- each portion configuring the hemostatic device can be substituted with any optional configuration which can fulfill the same function.
- any optional configuration element may be added thereto.
- the disclosure herein is also applicable to a hemostatic device used by being worn on a leg.
- the first layer is secured to the inner surface of the second layer.
- the first layer may not be secured to the inner surface of the second layer.
- the first layer protrudes from the gap portion in a state where the inflation portion is inflated.
- a configuration is not limited thereto as long as the first layer is exposed from the gap portion in the state where the inflation portion is inflated. That is, the gap portion may separate and allow the first layer to be exposed without the first layer protruding through the gap portion.
- the gap portion of the second layer is secured so as to be openable when the inflation space inside the inflation portion reaches a predetermined pressure.
- the gap portion of the second layer may not be temporarily secured before the inflation portion is inflated.
- the inflation portion interlocks with the band by means of fusion bonding.
- the inflation portion may not directly interlock with the band.
- the inflation portion interlocks with the band via a separate member. In this manner, a configuration is adopted so that the inflation portion is not detached from the band.
- the gap portion is formed on both the surface on the side facing the band in the second layer and the surface on the side facing the limb in the second layer.
- the gap portion may be formed in at least one location of the inflation portion.
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- Vascular Medicine (AREA)
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Abstract
Description
(Condition 2) In a state where the
(Condition 4) In a state where the
Claims (16)
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JP2016134608A JP6783083B2 (en) | 2016-07-06 | 2016-07-06 | Hemostatic device |
JP2016-134608 | 2016-07-06 |
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US20180008283A1 US20180008283A1 (en) | 2018-01-11 |
US10575859B2 true US10575859B2 (en) | 2020-03-03 |
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Cited By (1)
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US20190021742A1 (en) * | 2016-03-23 | 2019-01-24 | Terumo Kabushiki Kaisha | Hemostatic device |
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WO2016163326A1 (en) * | 2015-04-07 | 2016-10-13 | テルモ株式会社 | Tourniquet |
AU2017299466B2 (en) | 2016-07-18 | 2022-07-14 | Merit Medical Systems, Inc. | Inflatable radial artery compression device |
WO2019090104A2 (en) | 2017-11-03 | 2019-05-09 | Merit Medical Systems, Inc. | Hemostasis devices and methods of use |
EP3761867A4 (en) | 2018-03-09 | 2021-12-01 | Merit Medical Systems, Inc. | Ultrasound compatible inflatable vascular compression and related systems and methods |
EP3773257A4 (en) | 2018-04-11 | 2021-12-22 | Merit Medical Systems, Inc. | Inflatable compression device |
USD911516S1 (en) | 2018-06-19 | 2021-02-23 | Merit Medical Systems, Inc. | Hemostasis device |
US11596417B2 (en) | 2019-02-28 | 2023-03-07 | Terumo Kabushiki Kaisha | Hemostasis band with improved edge design |
CN113081146A (en) * | 2021-03-01 | 2021-07-09 | 太和县人民医院 | Hemostasis compressor with puncture part having continuous pressurization and humidity alarm functions |
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US20180008283A1 (en) | 2018-01-11 |
JP6783083B2 (en) | 2020-11-11 |
JP2018000762A (en) | 2018-01-11 |
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